Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00489294
• Date of registration: 19/06/2007
• Prospective Registration: No
• Primary sponsor: Phage Pharmaceuticals, Inc.
• Public title: Safety Study of Syntropin (Human Growth Hormone) for the Treatment of Growth Hormone Deficiency
• Scientific title: An Open-Label Study of the Pharmacokinetics and Pharmacodynamics of Syntropin (a Human Growth Hormone) in Growth Hormone-Suppressed Healthy Volunteers
• Date of first enrolment: August 2004
• Target sample size: 20
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00489294
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

United States

Key inclusion & exclusion criteria

Inclusion Criteria:

- Male and female subjects between the ages of 18 and 45 years (inclusive).

- Written informed consent to participate in the study.

- Body mass index between 19 and 31 kg/m².

- Female subjects of childbearing potential, defined as not surgically sterile or at
least 2 years postmenopausal, must agree to use one of the following forms of
contraception from 3 months prior through 7 days following the last dose of study
drug: hormonal (oral, transdermal, implant, or injection), barrier (condom,
diaphragm with spermicide), IUD, or vasectomized partner (6 months minimum).
Subjects must have used the same method for at least 3 months prior to starting the
study.

- No clinically significant abnormal findings on the physical examination, medical
history, electrocardiogram, or clinical laboratory results during screening.

- Screening growth hormone and insulin-like growth factor I (IGF-I) within normal
limits.

Exclusion Criteria

- A history of clinically significant gastrointestinal, renal, hepatic, neurologic,
hematologic, endocrine, oncologic, pulmonary, immunologic, psychiatric, or
cardiovascular disease or any other condition which, in the opinion of the Principle
Investigator, would jeopardize the safety of the subject or impact the validity of
the study results.

- A history of allergic or adverse responses to growth hormone, glycerin, or
metacresol, or any comparable or similar product.

- Subjects who (for whatever reason) have been on an abnormal diet during the four
weeks preceding the study.

- Subjects who donated blood within 30 days or plasma within 14 days of the first study
dosing.

- Participation in a clinical trial within 30 days prior to study initiation.

- Use of any over-the-counter (OTC) medication, including vitamins, within 7 days prior
to or during the study.

- Use of any prescription medication within 14 days prior to or during the study, with
the exception of hormonal contraceptives for women of childbearing potential.

- Treatment with any known enzyme altering drugs such as barbiturates, phenothiazines,
cimetidine, carbamazepine, etc., within 30 days prior to or during the study.

- Smoking or use of tobacco products within 6 months prior to or during the study.

- Female subjects who are trying to conceive, are pregnant, or are lactating.

- Positive serum pregnancy test at screening or urine pregnancy test prior to each drug
administration for all women regardless of childbearing potential.

- Positive blood screen for HIV, Hepatitis B surface antigen (HbSAg), or Hepatitis C,
or a positive urine screen for alcohol or drugs of abuse.



Age minimum: 18 Years
Age maximum: 45 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Growth Hormone Deficiency

Intervention(s)

Drug: Syntropin

Primary Outcome(s)

pharmacokinetics

Secondary Outcome(s)

serum concentrations of insulin-like growth factor-1 (IGF-1)

Secondary ID(s)

SYN-05-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors